Manufacturers have to go through a rigorous process to get approval from the U.S. Food and Drug Administration (FDA). Typically, drugs have to pass through four successful phases of clinical trials and manufacturers have to submit a New Drug Application (NDA) in order to get FDA approval. You hear about new drugs being approved all the time, but occasionally a drug gets denied.
Recently, the FDA denied the New Drug Application (NDA) from Cempra Pharmaceuticals for their new antibiotic, solithromycin.
What is a new drug application (NDA)?
A new drug application (NDA) is the way that manufacturers apply for drug approval from the FDA. This application is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed, and packaged.
The FDA tends to look at three key points when deciding if they are going to accept a drug’s NDA:
- Whether the drug is safe and effective, and whether the benefits outweigh the risks.
- Whether the drug’s proposed labeling (package insert) is appropriate and descriptive.
- Whether the methods used in manufacturing the drug, and the protocol used to maintain the drug’s quality, are adequate to preserve the drug’s identity, strength, quality, and purity.
Why was the NDA for solithromycin denied by the FDA?
The FDA decided to deny the new drug application for solithromycin for a few reasons. For one, the FDA asked for more clinical safety information about the toxicity of the drug, and the possible negative hepatic adverse effects. The FDA has requested that Cempra Pharmaceuticals complete a larger comparative study of at least 9,000 patients to more closely evaluate the potential for liver toxicity in patients.
The FDA also noted that the facilities in which solithromycin will be manufactured had some deficiencies. The manufacturer must resolve these deficiencies in these two manufacturing plants in order to get approval.
Keep in mind that this doesn’t necessarily mean that solithromycin won’t get approved in the future. It just means that the FDA wants to ensure the utmost safety of the drug.
What is solithromycin indicated for?
Solithromycin is indicated for the treatment of moderate to moderately-severe community acquired bacterial pneumonia (CABP) and urethritis.
What phase of clinical trials was solithromycin in?
Solithromycin was in stage 3 clinical trials. Generally, a phase three clinical trial is completed to confirm a medication’s effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In fact, during it’s clinical trials, solithromycin has been shown to be effective! The FDA didn’t request any more information on the drug’s efficacy when denying the NDA.
If solithromycin gets approved, what dosage forms will it be available in?
Solithromycin will be available in oral and intravenous dosage forms with plans for an ophthalmic form in the future.
To read more about the FDA’s denial, see the report here.
When asked about the medical conditions they fear the most, adults overwhelmingly answer dementia, specifically Alzheimers dementia. Treatment options for dementia are dismal, so the focus needs to be on prevention. Many risk factors for dementia are things you can control: diabetes, high blood pressure, physical inactivity and even some medications.
Multiple studies have found an association between the use of certain medication classes with dementia and cognitive (thinking, understanding, learning, remembering) impairment in older adults. For the medications on this list, the effects are worse at higher doses taken for extended periods of time. Most of these cognitive effects can be resolved if you stop the medication, but there is a chance that some may not.
In any case, if a medication can impact your mind long term, you should know. If you are taking any of the following medications, you might want to consider talking with your doctor about your risk for cognitive impairment and dementia.
- What do we know? The anticholinergic drugs that may impact the mind are tricyclic antidepressants, antihistamines, and overactive bladder medications. In a sample of adults, high doses of these medications were associated with an increased risk of dementia. Other studies have shown that the use of an anticholinergic medication was associated with brain atrophy and clinical decline.
- What meds are we talking about?
- Antihistamines like allergy medications. Over the counter allergy medications, called antihistamines, have anticholinergic properties that may increase the risk of dementia. Examples include Chlor Trimeton, Benadryl, Chlor-tab, and Aller-Chlor
- Sleep meds containing the active ingredient of Benadryl—diphenhydramine—like Sominex, Unisom, Advil PM, Aleve PM, and Tylenol PM.
- Tricyclic antidepressants like doxepin (Silenor), nortriptyline, and amitriptyline.
- Irritable bowel syndrome medications used for abdominal pain like hyoscyamine (Levsin) and dicyclomine (Bentyl).
- Overactive bladder medications like Enablex, Ditropan, Detrol, Sanctura, and Vesicare. This also includes medications used for large prostate and bladder symptoms like Toviaz.
Proton pump inhibitors
- What do we know? Studies suggest that men and women with dementia were 1.5 and 1.4 times more likely, respectively, to be taking proton pump inhibitors (PPIs). PPIs may cause accumulation of β-amyloid plaques. Malabsorbtion of vitamin B12 or other nutrients due to long-term PPI use could also play a role.
- What meds are we talking about?
- Omeprazole (Prilosec), lansoprazole (Prevacid), esomeprazole (Nexium)and pantoprazole (Protonix) are examples of proton pump inhibitors that can increase the risk for cognitive impairment and dementia, and have been in the news lately for this potential risk.
Opioid pain medications
- What do we know? Studies show a slightly higher dementia risk in people with heavy long-term use of opioid medications.
- What meds are we talking about?
- Morphine, hydrocodone (Vicodin), hydromorphone (Diladud) and fentanyl are examples of opioids that can increase risk for dementia.
Atypical benzodiazepines/insomnia meds
- What do we know? Insomnia medications, specifically ones that are part of the atypical benzodiazepines class, have been found to be associated with increased risk for dementia in the elderly population. Higher cumulative doses might even carry a bigger risk of developing dementia.
- What meds are we talking about?
- Ambien (zolpidem), Sonata (zaleplon) and Lunesta (eszopiclone) are examples of insomnia meds in the atypical benzodiazepine class that can increase risk.
To those suffering from dementia, or caring for a loved one who is, we are with you.
Edited 1/18/17 to include links to relevant studies.
Trying to navigate the over-the-counter (OTC) aisles to choose a pain or fever medication for your sick child can be an overwhelming task.
Sometimes it may feel like there are too many options. A lot of companies have multiple products, with similar names and packaging, which can make it difficult if you aren’t sure what you are looking for. However, basic knowledge of some popular children’s OTC medications can help simplify things.
What is the difference between infants’ Tylenol oral suspension and children’s Tylenol oral suspension?
In terms of the actual medication, there is no difference. Both the infants’ and children’s Tylenol liquid medications contain acetaminophen 160 mg/5 ml.
The only difference is that the infant product has a dosing syringe, whereas the children’s product has a dosing cup.
Can you alternate Tylenol and Motrin for fever or pain?
Yes. Since Tylenol and Motrin work differently on the body, you can alternate which you give your child.
How do I determine the dose for my child if they are under 2 years of age?
If your child is under 2, you should consult your pediatrician or healthcare provider.
Both Tylenol and Motrin products have a recommended dose based on your child’s weight—which means your healthcare provider will be able to determine what will be safest and most effective.
Is baby aspirin indicated for kids?
No! Even though the name can be deceiving, baby aspirin is a low dose aspirin that should not be used in children. In fact, baby aspirin is typically used for heart attack and stroke prevention in adults.
Children who are given aspirin can develop Reyes Syndrome, a serious and sometimes fatal side effect that causes swelling in the liver and brain. Learn more about Reyes Syndrome here.
Can I use a regular spoon to give my child their medicine?
No. Household silverware, such as a regular spoon, should never be used to give your child their medicine. The amount each spoon holds can be different, which means you are not getting an accurate dose. All liquid OTC products will come with their own measuring devices.
If you are picking up your child’s medicine at the pharmacy, be sure to ask the pharmacist for a dosing cup just in case!
My child is having problems keeping food or medicine down—can I still use an OTC medication to treat their fever or pain?
Yes! The main ingredient in Tylenol is acetaminophen, which is available without a prescription in a rectal suppository (for example, FeverAll).
If you are unable to find acetaminophen suppositories, check with your pharmacist to see if they have them on hand.
Unless you’ve been hiding under a rock, you’ve probably heard about the controversy regarding EpiPen pricing a few months back.
Why people got very upset about EpiPen prices:
EpiPen is a life-saving injector which provides immediate relief to severe allergic reactions. Unfortunately, it doesn’t work if you don’t have one handy, so parents often have to buy multiple pens to keep anywhere a child might be when they have a reaction. Insurance coverage varies—you might get coverage for a couple of pens at a time, or none at all. Thus, parents sending their kids back to school weren’t happy that they were potentially facing thousands of dollars in cost just to keep their kids safe.
Well, here’s some good news (finally):
Today, CVS significantly reduced the cash price for the authorized generic for Adrenaclick, another epinephrine auto-injector. CVS dropped the cash price for a two-pack of Adrenaclick injector pens to $109.99. To put this in perspective, the cash price for the same product is as high as $650 at other major chain pharmacies (and brand-name Adrenaclick is even more). That’s a really big drop. Bonus: this cash price is, well, just that—a cash price—so there are no coupons or paperwork required (except, of course, a prescription).
Why did CVS do this?
We reached out to CVS to learn more about the price decrease. Kevin Hourican at CVS told us that the company was “excited to offer generic Adrenaclick because we believe for most people it will be a much less expensive option than EpiPen. Our pharmacy staff is always available to help patients understand their medication costs under various health insurance and discount plans. This includes exploring every opportunity to enable patients to reduce their out-of-pocket costs by seeking cheaper but effective generic alternatives.”
What is Adrenaclick?
Adrenaclick contains the same active ingredient (epinephrine) as EpiPen; the big difference is that they have slightly different injectors. They’re basically the same drug in a different package; they are administered somewhat differently. EpiPen is more popular, but that may be just because that drug has been much more aggressively advertised for quite some time.
What do I need to do to get this price?
The best thing about this new low price is that it’s a cash price, which makes purchasing this prescription super-simple. Obviously, you’ll need a valid prescription, but that’s about it.
Learn more about the CVS announcement here.
More is not always better. More tests, more treatments and more visits to the doctor may not always be the way to go. Unnecessary tests or medications can lead to anxiety, side effects, and follow-up tests that are more harmful than helpful to your health. The saying in medicine is “imaging begets more imaging,” and radiology studies often bring about a cascade of unnecessary follow-ups.
Is that to say that all screening tests are bad? No—and many save lives. Here are ten interventions, however, that have not been shown to be helpful.
- Aspirin, for young folks. Most young people taking aspirin for prevention of stroke and heart disease don’t need it. The current evidence is insufficient to assess the balance of benefits and harms of initiating aspirin use for the primary prevention of cardiovascular disease or colorectal cancer in adults younger than 50 years. So, there’s that.
- A urine test and urine culture during a physical. For men and non-pregnant women, screening for bacteria in the urine if you are not having symptoms is not recommended nor is it helpful.
- A Pap smear in women who have had a hysterectomy and have no cervix. If you’re a woman who has had a hysterectomy with removal of the cervix and you do not have a history of cervical cancer, or a high-grade precancerous lesion (cervical intraepithelial neoplasia [CIN] grade 2 or 3), you do not need screening with a pap. There is nothing to screen.
- A Pap smear in women younger than 21. Current recommendations say no to screening for cervical cancer with a Pap in women younger than 21, even if they’ve been sexually active. Newsflash: women can wait until they are 21 to have their first Pap.
- Carotid artery ultrasound (also known as a carotid artery duplex scan). Current recommendations do not support screening for carotid artery stenosis in the general adult population if you are not having any symptoms of stroke or mini-stroke (TIA). So unless you have unexplained weakness, numbness, tingling, visual changes, or dizziness, you do not need this done.
- Screening for abdominal aortic aneurysm. Though recommended for some adults, like men who are heavy smokers, most of you do not need an ultrasound to screen for an aneurysm. For women who have never smoked, there is no need to screen for an abdominal aortic aneurysm.
- EKG and heart stress test for adults at low risk. Adults who are not having symptoms (chest pain, shortness of breath, decreased exercise tolerance etc.) and are low risk do not need screening with a resting or exercise electrocardiography (ECG or EKG) for the prediction of coronary heart disease events. Low risk means you don’t have: diabetes, family history of early heart attacks, uncontrolled hypertension, and so on. A routine EKG in a healthy person without symptoms is not needed and does not save lives.
- Genetic tests for breast cancer. Genetic counseling or BRCA testing (BRCA 1 or 2 genes) for women whose family history is NOT associated with increased risk is NOT recommended. How do you know if your family is at risk? Check out this article.
- Herpes blood test in people without any symptoms/genital lesions. Routine blood tests for HSV (herpes simplex virus) is not recommended for teens and adults who have no symptoms. Remember, the blood test is positive in many people who have been exposed but may never develop a lesion. The blood test is not helpful to predict who may have outbreaks and who may not. A viral culture done on an actual sore in the mouth or genitals is the way to make the diagnosis of herpes.
- Hormone replacement therapy (HRT) in all postmenopausal women. To prevent chronic conditions (heart disease and stroke) in postmenopausal women, the combined use of estrogen and progestin is not recommended. Downsides outweigh upsides here.